Cognitive Flexibility Training for Persistent Pain: Neuroimaging Pilot (COFLEX-i)

The Washington University

Status: Completed

Conditions: Back Pain; Chronic Pain; Knee Pain Chronic; Hip Pain Chronic

Treatments: Behavioral: Cognitive Training + fMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03720821

201808143

Details and patient eligibility

About

To determine whether a 5-week computer-based cognitive training intervention results in changes in resting-state functional connectivity (rsFC) within the brain networks.

Full description

This project is a single-center prospective pilot study to assess whether cognitive flexibility training through a Lumosity®-based training module over the course a five week timeframe in patients with chronic hip, knee, and back pain results in detectable changes in resting-state functional connectivity (rsFC). The investigators will explore changes in rsFC particularly within the default mode (DMN), frontoparietal (FPN), and cingulo-opercular (CON) brain networks.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults between 18 to 70 years old with chronic hip, knee or back pain for >3 months
• Documented moderate to severe chronic pain
• English fluency
• Access to a computer at home and an email account

Exclusion criteria

• Lack of email/lack of basic computer skills
• Diagnosed Alzheimer's or documented severe cognitive impairment
• Severely impaired vision or color blindness
• Unable to complete cognitive testing
• An interventional pain procedure within one week prior to enrollment testing
• Scheduled to undergo a pain procedure during the five weeks of cognitive training
• Self-reported claustrophobia
• Contraindication to an MRI scan (i.e. presence of metallic foreign body such as an artificial joint or aneurism clip, implanted pacemaker or spinal cord stimulator)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Cognitive Training + fMRI

Experimental group

Description:

Participants will complete Trail Making Test (TMT) A \& B (both electronic and paper-pencil), the paper-pencil Color-Word Matching Stroop Test (CWMST), and its electronic version called "Color Match", and a computer-based subset of NCPT (Neurocognitive Performance Test). In addition, participants will also complete Brief Pain Inventory (BPI), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), and the Resilience Scale questionnaires at baseline. Participants will be provided with the cognitive training module and participants will be required to complete a targeted 36-minute daily training for 35 days. Participants will be asked to undergo 2 functional magnetic resonance imaging (fMRI) sessions. One prior to, and one after the 5-week cognitive training period.

Treatment:

Behavioral: Cognitive Training + fMRI